High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus

NCT05457088 | Completed

• 1 other identifier: 1288/03-07-2021
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the impact of dietary protein intake on progressive muscle loss and functionality (sarcopenia) in older adults with type 2 diabetes mellitus. Sarcopenia is known to have a bidirectional interaction with type 2 diabetes mellitus. Therefore in order to address this bidirectional complication we suggest that an increased intake of dietary protein at 1.5 gr/kg/day (current official recommendation is 0.8 gr/kg/day) could help to treat the sarcopenia, which in turn will help to ameliorate the type 2 diabetes mellitus progression.

Conditions

Type2 Diabetes Mellitus

Keywords

older adults; dietary protein; nutrition intervention; sarcopenia; performance; oxidative stress; inflammation; biochemical profile

Outcome Measures

Primary Outcomes (11)

• skeletal muscle mass index

  Change from baseline in skeletal muscle mass index and will be assessed by dual energy x-ray absorptiometry ((leg lean mass+arm lean mass)/height\^2)

  Week 0, week 12

• calf circumference

  Change from baseline in calf circumference and will be assessed by measuring tape

  Week 0, week 6, week 12

• handgrip strength

  Change from baseline in handgrip strength and will be assessed by handgrip dynamometer

  Week 0, week 6, week 12

• Sit to stand test

  Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer

  Week 0, week 6, week 12

• Timed up and go test

  Change from baseline in "Timed up and go" test which measures muscle functionality and will be assessed by chronometer

  Week 0, week 6, week 12

• 10 meters walking test

  Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer

  Week 0, week 6, week 12

• blood glucose

  Change from baseline in blood glucose and will be assessed by commercially available kit

  Week 0, week 6, week 12

• Serum insulin

  Change from baseline in serum insulin and will be assessed by commercially available kit

  Week 0, week 6, week 12

• Glycosylated hemoglobin (HbA1)

  Change from baseline in HbA1 and will be assessed by commercially available kit

  Week 0, week 6, week 12

• C reactive protein

  Change from baseline in C reactive protein and will be assessed by commercially available kit

  Week 0, week 6, week 12

• Dietary intake of macro- and micro-nutrients

  Change from baseline in macro- and micro- nutrients and will be assessed with -3 day recall

  Week 0, week 3 , week 6, week 9, week 12

Secondary Outcomes (9)

• cholesterol level

  Week 0, week 6, week 12

• triglycerides level

  Week 0, week 6, week 12

• low-density lipoprotein (LDL)

  Week 0, week 6, week 12

• high-density lipoprotein (HDL)

  Week 0, week 6, week 12

• Enzymatic activity of glutathione peroxidase in plasma

  Week 0, week 6, week 12

Study Arms (2)

intervention group

EXPERIMENTAL

Dietary intervention with protein intake 1.5 gr/kg/day

Other: 1.5 protein

control group

EXPERIMENTAL

Dietary intervention with protein intake 0.8 gr/kg/day

Other: 0.8 protein

Interventions

1.5 protein OTHER

dietary plan having dietary protein of 1.5 gr/kg/day

intervention group

0.8 protein OTHER

dietary plan having dietary protein of 0.8 gr/kg/day

control group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must have been diagnosed with type 2 diabetes mellitus during the last 5 years
• must have BMI 18.5-34.9

You may not qualify if:

• receive dietary supplements
• extreme dietary habits
• chronic inflammation disease
• cancer
• autoimmune disease

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Harokopio University: collaborator

Study Sites (1)

National and Kapodistrian University of Athens

Athens, Attica, Greece

Location

Related Publications (1)

• Argyropoulou D, Geladas ND, Nomikos T, Paschalis V. Exercise and Nutrition Strategies for Combating Sarcopenia and Type 2 Diabetes Mellitus in Older Adults. J Funct Morphol Kinesiol. 2022 Jun 8;7(2):48. doi: 10.3390/jfmk7020048.

  PMID: 35736019 RESULT

MeSH Terms

Conditions

Sarcopenia; Inflammation

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1st group will receive a dietary plan having dietary protein of 1.5gr/kg/day.2nd group will receive a dietary plan having dietary protein of 0.8gr/kg/day.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: November 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GR (1)